COVID-19 Update

FDA Prioritizes Vaccine Approvals and Process Improvements; image: W.Scott McGill - stock.adobe.com

FDA Prioritizes Process Improvements

Better coordination in development and review of vaccines is needed.

Subunit Vaccines and the Fight Against COVID-19

Advances in technology are accelerating the development and manufacture of subunit vaccines.

Meeting the Demand for Lipid Excipients

Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.

ECDC and EMA Issue Advice on Fourth Doses of mRNA COVID-19 Vaccines

April 08, 2022

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

Pfizer and BioNTech Receive Expanded US Emergency Use Authorization for an Additional COVID-19 Vaccine Booster

April 06, 2022

FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.

AstraZeneca’s Antibody Combination Authorized for Use in Great Britain for Prevention of COVID-19

March 21, 2022

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.

Moderna and the Japanese Government Reach an Agreement to Supply Japan with Additional 70 Million Doses of Moderna’s COVID-19 Booster Vaccine

March 21, 2022

Moderna has reached an agreement with the Ministry of Health, Labor, and Welfare of Japan (MHLW) to supply Japan with an additional 70 million doses of its COVID-19 Booster Vaccine.

COVID-19 Vaccine Manufacturers Submit Appeals to FDA for Fourth Dose

March 21, 2022

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

EMA Recommends Updated Product Information for Moderna and Janssen COVID-19 Vaccines

March 16, 2022

EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to product information.

The Next Step For COVID-19 Vaccines

March 09, 2022

New technologies are treatments are emerging to tackle COVID-19 and its assortment of new variants.

Johnson & Johnson COVID-19 Vaccine to be Manufactured in Africa

March 08, 2022

Johnson & Johnson have announced a landmark agreement to enable the manufacturing and availability of its COVID-19 vaccine in Africa by an African company.

Moderna to Establish its First mRNA Manufacturing Facility in Africa

March 08, 2022

Moderna has announced that it has entered a Memorandum of Understanding with the government of the Republic of Kenya to establish its first mRNA manufacturing facility in Africa.

Evonik Increases Global Supply of Pharma-Grade Plant-Derived Cholesterol for mRNA Vaccines and Gene Therapies

March 04, 2022

Evonik has increased its global supply of plant-derived cholesterol used for mRNA vaccines and gene therapies.